The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns

NCT04625010 | Completed

• 1 other identifier: IstanbullUC
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to evaluate the effect of two different non-pharmacologic pain relief methods (swaddling and maternal holding) on healthy term newborn's pain levels during heel stick. Study hypotheses are; Hypothesis 1. Swaddling is effective at relieving pain due to heel stick procedures in newborns. Hypothesis 2. Maternal holding is effective at relieving pain due to heel stick in newborns. Hypothesis 3. Maternal holding is more effective than swaddling at relieving pain due to heel stick in newborns.

Conditions

Newborn; Pain; Maternal; Procedure; Needle Stick

Keywords

Newborn; Pain management; Swaddling; Maternal holding; Heel stick

Outcome Measures

Primary Outcomes (1)

• NIPS (Neonatal Infant Pain Scale)

  Neonatal Infant Pain Scale: NIPS was developed by Lawrence et al. (1993)21 to evaluate behavioral and physiologic pain responses of preterm and term infants. The scale was adapted to Turkish by Akdovan (1999)22. In the present study, NIPS was used to evaluate the interventional (procedural) pain level of newborns. The scale consists of five behavioral (facial expressions, crying, wakefulness, arm and leg movements) and a physiologic (breathing) signs; 0-2 points are given to the crying indicator, 0-1 points are given to other indicators, and the total score is between 0 and 7. High scores indicate that the severity of pain is excessive.

  Pain levels of the newborns evaluated during the procedures

Secondary Outcomes (2)

• Total criying time

  The time of the procedure was measured from the beginning to the end of the heel stick procedure.

• The time to first calming

  Procedure (The calming time was measured from the time of the first cry to the first calming time.)

Study Arms (3)

Group 2 (Swaddling group)

EXPERIMENTAL

Swaddling group: Swaddling is a wrapping procedure in which a baby's arms and legs are comfortable, sometimes only the arms are wrapped inside, and two ends of fabric are crossed on the chest of the baby, generally with thin cotton and soft fabric or a blanket. In the swaddling group, neonates were placed in the supine position on a blanket. In compliance with the newborn anatomic posture, the legs were wrapped in the flexion and abduction position. The arms of the neonates were placed close to their torso with both hands, without restraining limb movements. Swaddling was carried out 1 minute before the heel stich procedure and continued 3 minutes after the procedure. The neonate remained on the examination table during the swaddling procedure. Swaddling was applied not too loose or too tight during the procedure.

Other: Swaddling

Group 3 (Maternal Holding group)

EXPERIMENTAL

Maternal holding group: Neonates in this group were held in their mothers' lap while their mothers were seated reclining on a comfortable chair. Neonates remained clothed in their mothers' lap during the heel stick procedure, and no breastfeeding was administered during the procedure. Holding was continued for a minimum of 3 minutes during and after the procedure.

Other: Maternal holding

Group 1

NO INTERVENTION

In the control group, the heel stick procedures were conducted using the standard method and the neonates received no interventions during the procedures.

Interventions

Swaddling OTHER

Swaddling is a wrapping procedure in which a baby's arms and legs are comfortable, sometimes only the arms are wrapped inside, and two ends of fabric are crossed on the chest of the baby, generally with thin cotton and soft fabric or a blanket. In the swaddling group, neonates were placed in the supine position on a blanket. In compliance with the newborn anatomic posture, the legs were wrapped in the flexion and abduction position. The arms of the neonates were placed close to their torso with both hands, without restraining limb movements. Swaddling was carried out 1 minute before the heel stich procedure and continued 3 minutes after the procedure. The neonate remained on the examination table during the swaddling procedure. Swaddling was applied not too loose or too tight during the procedure.

Also known as: Group 2

Group 2 (Swaddling group)

Maternal holding OTHER

Neonates in this group were held in their mothers' lap while their mothers were seated reclining on a comfortable chair. Neonates remained clothed in their mothers' lap during the heel stick procedure, and no breastfeeding was administered during the procedure. Holding was continued for a minimum of 3 minutes during and after the procedure.

Also known as: Group 3

Group 3 (Maternal Holding group)

Eligibility Criteria

• Age: 2 Days - 4 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• full term neonates (38-42 weeks of gestation)
• underwent heel stick blood drawing for routine metabolic screening,
• aged 2 to 4 days
• passed the hearing screening

You may not qualify if:

• Congenital anomalies

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Bandırma Onyedi Eylül University: collaborator

Study Sites (1)

Sevil İnal

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

Location

Related Publications (7)

• Gradin M, Eriksson M, Holmqvist G, Holstein A, Schollin J. Pain reduction at venipuncture in newborns: oral glucose compared with local anesthetic cream. Pediatrics. 2002 Dec;110(6):1053-7. doi: 10.1542/peds.110.6.1053.

  PMID: 12456899 BACKGROUND

• Obeidat HM, Shuriquie MA. Effect of Breast-Feeding and Maternal Holding in Relieving Painful Responses in Full-Term Neonates: A Randomized Clinical Trial. J Perinat Neonatal Nurs. 2015 Jul-Sep;29(3):248-54. doi: 10.1097/JPN.0000000000000121.

  PMID: 26218818 RESULT

• Okan F, Ozdil A, Bulbul A, Yapici Z, Nuhoglu A. Analgesic effects of skin-to-skin contact and breastfeeding in procedural pain in healthy term neonates. Ann Trop Paediatr. 2010;30(2):119-28. doi: 10.1179/146532810X12703902516121.

  PMID: 20522298 RESULT

• Harrison D, Reszel J, Bueno M, Sampson M, Shah VS, Taddio A, Larocque C, Turner L. Breastfeeding for procedural pain in infants beyond the neonatal period. Cochrane Database Syst Rev. 2016 Oct 28;10(10):CD011248. doi: 10.1002/14651858.CD011248.pub2.

  PMID: 27792244 RESULT

• Karakoc A, Turker F. Effects of white noise and holding on pain perception in newborns. Pain Manag Nurs. 2014 Dec;15(4):864-70. doi: 10.1016/j.pmn.2014.01.002. Epub 2014 Feb 20.

  PMID: 24559599 RESULT

• Morrow C, Hidinger A, Wilkinson-Faulk D. Reducing neonatal pain during routine heel lance procedures. MCN Am J Matern Child Nurs. 2010 Nov-Dec;35(6):346-54; quiz 354-6. doi: 10.1097/NMC.0b013e3181f4fc53.

  PMID: 20926970 RESULT

• Cong X. Heel stick test for obtaining blood samples in neonates: both swaddling and heel warming may help, but heel warming appears to provide greater pain reduction. Evid Based Nurs. 2015 Oct;18(4):118. doi: 10.1136/eb-2014-102048. Epub 2015 Apr 16. No abstract available.

  PMID: 25883132 RESULT

MeSH Terms

Conditions

Pain; Needlestick Injuries; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds, Stab; Wounds, Penetrating; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Leyla Erdim, Dr

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Prospective, randomized controlled trial

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 30, 2016
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)